A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer

An Open-label Pilot Study Evaluating the Effect of a Combination Regimen of Herceptin, Cisplatin, and Gemcitabine on Time to Disease Progression in Patients With Metastatic Urothelial Cancer

This study will evaluate the efficacy and safety of a chemotherapy regimen of intravenous Herceptin, cisplatin and gemcitabine in patients with metastatic urothelial cancer. The anticipated time on study treatment is until disease progression.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Cancer
• Intervention / Treatment: Drug: trastuzumab; Drug: gemcitabine; Drug: cisplatin

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Aschersleben, Germany, 06449
  • Dessau, Germany, 06846
  • Fulda, Germany, 36043
  • Leipzig, Germany, 04103
  • Leipzig, Germany, 04277
  • Marburg, Germany, 35043
  • Weiden, Germany, 92637

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients with >=18 years of age;
• metastatic urothelial carcinoma;
• measurable metastases or local recurrent disease;
• no prior chemotherapy for metastatic disease;
• HER2 overexpression (IHC [2+] or [3+]).

Exclusion Criteria:

• concomitant chemotherapy or immunotherapy;
• active or uncontrolled infection;
• solely CNS metastases;
• clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
• co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Trastuzumab, Gemcitabine, Cisplatin; Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.) on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v until disease progression; 1200 mg per square meter (m2) gemcitabine i.v. on Days 1, 8, and 15 of Cycles 1 through 6; and 70 mg/m2 cisplatin i.v. on Day 2 of Cycles 1 through 6.

Drug: trastuzumab; 4 mg/kg i.v., Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v., Day 1 of Cycle 2 until disease progression; Other Names: Herceptin; Drug: gemcitabine; 1200 mg/m2 i.v. on Days 1, 8, and 15 of Cycle 1 through 6; Drug: cisplatin; 70 mg/m2 i.v. on Day 2 of Cycles 1 through 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) - Percentage of Participants With an Event	PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause.	Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months
Progression-Free Survival - Time to Event	The median time, in months, from the first dose of study treatment to PFS event.	Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months
Percentage of Participants Who Were Progression Free at 12 and 24 Months		Screening, and Months 12 and 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) - Percentage of Participants With an Event	OS was defined as the time from the start of study treatment to date of death due to any cause.	Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months
Overall Survival - Time to Event	The median time, in months, from the start of study treatment to OS event.	Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months
Percentage of Participants Surviving at 12 and 24 Months		Screening, and Months 12 and 24
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)	Per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1): CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal [(short axis less than (<) 10 millimeters (mm)]. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as not qualifying for CR, PR, or Progressive Disease (PD).	Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: December 5, 2013
• First Submitted That Met QC Criteria: December 5, 2013
• First Posted (Estimate): December 10, 2013

Study Record Updates

• Last Update Posted (Estimate): February 11, 2015
• Last Update Submitted That Met QC Criteria: February 9, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Gemcitabine; Trastuzumab; Cisplatin
• Other Study ID Numbers: ML17600